28th & 29th October 2020
28th & 29th October 2020
Paris
28th & 29th October 2020
Paris Marriott Rive Gauche Hotel & Conference Center
Paris Marriott
Sponsored by
17 Boulevard Saint-Jacques, 75014 Paris, France
BACKGROUND
Regulatory initiatives in the European Union (EU) have resulted in proposed classifications for all poorly soluble low toxicity particles (PSLTs) for carcinogenicity. Examples of PSLTs include carbon black, titanium dioxide and iron oxide, among
others. Approaches have also been proposed for setting workplace exposure limits for these materials, such as by the German MAK Commission.
This scientific conference will facilitate interaction and discussions among attendees with expertise in toxicology, epidemiology, occupational and pulmonary medicine and exposure assessment. The purpose of this conference is to promote interactions between these different disciplines to aid in the sound and evidence-based scientific
underpinning of regulatory standard considerations regarding PSLTs. Although regulatory concern regarding PSLTs has focused on lung cancer risk as a result of rat inhalation overload studies, this conference will address all relevant health end points, including genetic and reproductive issues as well, consistent with ECHA guidelines.
Scientific Program Committee
Robert McCunney MD, MPH (Chair), Nathan Baker, Len Levy PhD, Kevin Driscoll PhD, Paul Borm PhD,
Nils Krueger DVM, Dominique Lison MD, PhD, Lang Tran PhD, Rodger Duffin PhD, Vicki Stone PhD
SAMPLE OF TOPICS
Sample of Topics related to substances that may be characterized as PSLTs, including carbon black, coal, titanium dioxide, cerium oxide, aluminum oxide barium sulfate and iron oxide, among others.
-
Defining PSLTs
-
Epidemiological studies of PSLTs
-
Inhalation studies evaluating human cellular response to particles
-
Basic research studies on inflammatory to malignancy pathways
-
Animal studies, PLSTs and human risk: “New Insights into old data.”
-
New studies on PSLTs; 2 year carcinogenicity assays; Role of the rodent model in human risk assessment of PSLTs and lung cancer risk
-
Animal studies and gender specific responses to PSLTs. How does the USA National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) address this challenge of extrapolating rodent data to human risk assessment?
-
Adverse Outcome Pathways (AOPs) and Modes of Action (MOA): identification and recommendations for closing gaps in knowledge for rodents and humans.
-
Are there lessons to be learned from how the pharmaceutical industry’s approach to translational science (safety and efficacy) as evolved in recent years?
-
Setting exposure limits for PSLTs and Translational Toxicology.
-
Genotoxicity and Reproductive toxicity studies of PSLTs.
-
Nanoparticle inhalation – kinetics, bioprocessing and non-pulmonary responses.
Conference supported by a grant from the International Carbon Black Association
CONFERENCE GOALS
-
Address scientific studies regarding human health effects of PSLTs. The value of human studies over animal studies-when human-exposed populations can be studied adequately- will be emphasized.
-
Review and discuss definition of PSLT’s proposed at Edinburgh workshop and published in 2020 in the Journal Inhalation Toxicology with attention to both similarities and differences among these substances.
-
Address translational toxicology challenges, including the appropriateness of rats as models for human lung pathogenesis (particularly lung cancer) in light of lung overload phenomena and species differences.
-
Serve as a platform to present current scientific information about PSLTs important for regulatory action.
-
Publication of pertinent conference presentations in the peer reviewed scientific literature will allow the presentations to live beyond the conference and subsequently be reviewed part of regulatory deliberations.
-
Establish an interdisciplinary setting for industry, academia and regulatory professionals to interact on an important topic. Such interaction can facilitate enhanced understanding of the science and appropriate classification,
labeling and setting exposure limits, among others.
-
Recommend areas for further research regarding the significance of the rat as
a model for translation toxicology.
-
Review the biokinetics of inhaled nanoparticles and the potential for non-pulmonary effects.
WEDNESDAY 2OTH OCTOBER
DAY 1
MORNING SESSION
HUMAN STUDIES
Theme: Role of Human Studies, including epidemiology, in assessing health risk
Key note:
-
IOM and Particles; a long history in research and service in protecting human health - Nathan Baker
-
Role of epidemiology in human risk assessment - Ken Mundt, PhD
-
Carbon Black and Lung Cancer Mortality - A Meta-regression Analysis Based on Three Occupational Cohort Studies - M. Yong, MD, PhD
-
Coal and mortality - Robert McCunney, MD, MPH
-
PSLT's and Lung Function and Malignancy: Casual Inference Analysis - Phil Harber, MD, MPH
-
Pulmonary Inflammation, asthma and exhaled nitic oxide - Chris Fanta, MD
Panel:
Moderated by Robert McCunney, MD, MPH
Panelist - Robert Blink, MD
-
PSLT's and lung cancer; What do the epidemiology and human inhalation studies tell us?
Lunch:
-
Luncheon address; Medical Publishing Today - Paul Brandt-Rauf, MD, ScD
AFTERNOON SESSION
ANIMAL STUDIES
Theme: Inflammation as a key adverse outcome pathway in particle induced effects
Key note:
-
Macrophages, inflammation and lung cancer in 2021 - Dominique Lison, MD, PhD
-
Particle induced Inflammation and lung cancer: Outcome of Edinburgh Workshop - Kevin Driscoll, PhD
-
Inflammatory pathways in humans - a broader perspective - Rodger Duffin, PhD
-
Pulmonary Cell proliferation: The missing link in PSLTP-Induced Lung Cancer. A pathologist's perspective - Jack Harkema, DVM
Theme: Challenges provided by GHS based target organ toxicity - design and interpretation of inhalation studies of new and existing materials
-
Pathology to be reconsidered? Oral and inhalation studies - Klaus Webber, PhD
-
Wrap up and Summary - Alison Elder, PhD
Panel:
Moderated by Paul Borm, PhD and Alison Elder, PhD
Panelist - Ann Hubbs, DVM
-
Is pulmonary inflammation the key adverse effect?
-
Are sub chronic animal studies adequate?
-
Are effects noted adaptive or adverse?
EVENING DINNER
-
Sit down dinner for all delegates
THURSDAY 21ST OCTOBER
DAY 2
MORNING SESSION
NANOPARTICLE TOXICOLOGY - NON-PULMONARY EFFECTS
Key note:
-
Nanotechnology and health - Vicki Stone, PhD
-
Toxicokinetics of inhaled nanoparticles - Otto Creutzenberg, PhD
-
Dose - and Dosi-Metric Aspects and Biokinetics of Inhaled Poorly Soluble Low Toxicity (PSLT) Particles in Lung Overload - Gunter Oberdoerster, PhD
-
In Vivo processing of nanoparticles-influence on toxicity - Uschi Graham, PhD
-
Genotoxicity of multi-walled carbon nanotube reference materials in mammalian cells and animals - Peter Moller, PhD
-
Neurotoxicity of Nanoparticles - Raul Schins, PhD
-
Reproductive and developmental toxicity - Karin Hougaard, PhD, MSc, BM, ERT
-
Occupational exposure to carbon black and risk of cardiovascular disease - Robert McCunney, MD, MPH
-
Wrap up and summary - Kevin Driscoll, PhD and Annie Jarabek, PhD
Lunch:
Luncheon address; Microplastics and Health: A new challenge for regulators and scientists - Stephanie Wright, PhD
AFTERNOON SESSION
REGULATORY APPLICATION OF SCIENCE
Key note:
-
Regulatory application of science to Particles and Health - some introductory observations - Len Levy ,PhD
-
Regulatory application of science and stake holder engagement - setting EU Occupational Exposure Limits - Alick Morris
-
Testing materials in a world of reduced emphasis on animal testing; OECD Guidelines - Thomas Kuhlbusch
-
Applying translation science approaches to protect workers exposed to nanomaterials - Paul Schulte, PhD
-
Can we reduce animal testing? A tiered approach based on in-vitro screening - Martin Wiemann
-
NANOSCREEN: Assessing the impact of SAS particles on advanced in-vitro intestine models - Peter Wick
-
Acute Inhalation Toxicity Part 1: The challenge to create particulate aerosols for acute toxicity testing - a systematic approach - Juergen Nolde, PhD
-
Acute Inhalation Studies Part 2: Non-specific particle effects now trigger classification - Nils Krueger, PhD, DBM
Panel
Moderated by Len Levy, PhD, Nils Krueger, PhD, DVM
Panelist - Tim Bowmer
-
The art of regulation; what the regulators need from the scientists
-
Putting regulatory decisions in to practice to protect workers, involving stakeholders
-
Non-specific inflammatory responses as a basis for classification?
-
Adaptive and reversible effects as triggers for regulation?
-
Can we predict effects without further animal studies?
-
Can we move away from rodents for effects in the lung-better use of human and in-vitro data?
CONFERENCE CLOSES
SCHEDULE
Don’t Miss Out
